US FDA approves Vandas drug for treatment of bipolar disorder
Fanapt (iloperidone) from Vanda Pharmaceuticals has received FDA approval for the acute management of manic or mixed episodes linked to adult bipolar I illness. Based on the outcomes of a Phase III clinical trial with 400 patients enrolled, the approval was granted. With significant gains evident after two weeks of treatment, the primary goal of a higher success rate than placebo was reached after four weeks. Vanda said that the expanded indication for Fanapt, which was first licenced in 2009 to treat patients with schizophrenia, will give patients variable dosage and a well-established safety profile. In the US, bipolar disorder affects approximately 5.7 million adults, with a 25-year typical onset age. Bipolar disorder may run in families because most persons who are diagnosed with it have a family member who also has the illness or who suffers from severe depression. With this FDA approval, bipolar I disorder management options for patients and service providers are expanded. Based on encouraging findings from two placebo-controlled Phase III clinical trials comparing the medication to active control and placebo in schizophrenia patients, Vanda Pharmaceuticals approved Fanapt for treatment in 2009. Before overturning its earlier judgement, the FDA had denied Vanda's New Drug Application for Fanapt nearly a year earlier.
